BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRA METER

    MDR report key: 1211561 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02744
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH ULTRA METER WAS REVERTING TO SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND RECORDED PHONE CONVERSATION. THE PATIENT TESTS HER BLOOD SUGAR 5-6 TIMES A DAY AND MANAGES HER DIABETES WITH INSULIN (HUMULIN) THAT IS TAKEN BASED ON METER READINGS. SOMETIME LAST WEEK, THE PATIENT NOTICED THAT THE METER WAS REVERTING BACK TO SETUP MODE AND REPORTEDLY DECREASED 15 UNITS OF HUMALIN BECAUSE SHE DOES NOT KNOW HER BLOOD GLUCOSE RESULT. AT AN UNSPECIFIED TIME AFTER THE METER ISSUE, THE PATIENT CLAIMED THAT SHE FELT WEAK, SWEATY, DISORIENTED AND HAD BLURRY VISION; SO SHE DRANK SOME ORANGE JUICE AND TOOK A GLUCOSE TABLET. IT IS UNKNOWN WHETHER THE PATIENT FELT BETTER AFTER ADMINISTERING SELF-TREATMENT. THERE WAS NO BACKUP DEVICE TO TEST HER BLOOD GLUCOSE WITH. THIS WAS NOT A NEW OUT OF BOX PRODUCT AND THERE WAS NO METER TRAUMA. THE ALLEGED ISSUE REPORTEDLY OCCURRED IMMEDIATELY AFTER THE BATTERIES WERE REPLACED. THE CSR WAS ABLE TO RESOLVE THE ISSUE THROUGH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENTS PRODUCTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2798238

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R